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Clinical Trials/NCT07571811
NCT07571811Not yet recruitingNot Applicable

Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery

Boston Children's Hospital1 site in 1 country10 target enrollmentStarted: May 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
10
Locations
1
Primary Endpoint
Maximum plasma concentration (Cmax) of fetal anesthesia

Study Overview

Brief Summary

This study examines how three medications commonly used during fetal surgery, fentanyl, rocuronium, and atropine, behave in the fetus. The primary goal is to understand their pharmacokinetics (how the drugs are absorbed, distributed, and cleared), pharmacodynamics (how they affect fetal physiology), and how they transfer between mother and fetus through the placenta. The secondary goal is to measure drug levels in discarded fetal blood samples collected during clinically indicated procedures and relate those levels to fetal heart rate, heart rate variability, movement, gestational age, and fetal size. An optional maternal blood draw component will allow comparison of maternal and fetal drug concentrations to better understand placental transfer. The study does not change clinical care or require extra fetal procedures, and findings may help create safer, evidence-based fetal anesthesia dosing strategies tailored to gestational age.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
13 Years to — (Child, Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Pregnant and undergoing maternal-fetal surgery requiring clinically indicated fetal anesthesia and planned fetal blood sampling as part of usual fetal care
  • Fetus is with or without congenital heart disease

Exclusion Criteria

  • Patient or fetus have any known liver or kidney disease
  • Patient or fetus has any known allergy to fentanyl, rocuronium, or atropine
  • Patient has taken inhibitors, inducers or substrates of CYP3A4 other than midazolam (including erythromycin, ranitidine, verapamil, antihistamines, and dextromethorphan) within 24 hours of surgery.

Arms & Interventions

Pregnant women undergoing maternal-fetal surgery

Pregnant women undergoing maternal-fetal surgery requiring fetal anesthesia. This study is purely observational.

Outcomes

Primary Outcomes

Maximum plasma concentration (Cmax) of fetal anesthesia

Time Frame: 2 years

Characterize the plasma concentrations / pharmacokinetics profile, specifically the peak plasma concentration (Cmax) of commonly used fetal anesthetics, investigate the pharmacodynamic effects of anesthetics on fetus, assess the maternal-fetal transfer of anesthetics during surgery, and identify potential variations during different stages of fetal development.

Area under the plasma concentration versus time curve (AUC) of fetal anesthesia

Time Frame: 2 years

Characterize the plasma concentrations / pharmacokinetics profile, specifically the area under the plasma concentration versus time curve (AUC) of commonly used fetal anesthetics, investigate the pharmacodynamic effects of anesthetics on fetus, assess the maternal-fetal transfer of anesthetics during surgery, and identify potential variations during different stages of fetal development.

Secondary Outcomes

  • Maternal blood concentration of fetal anesthesia(2 years)
  • Fetal blood concentration of maternal anesthesia(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gwen Owens

Instructor of Anesthesia, Harvard Medical School

Boston Children's Hospital

Study Sites (1)

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